Start of mission
November 18, 2019
Job city
Marseille (13008)
Type of contract
CDD/ Fixed Term Contract

Description

Overall Objectives and Purpose of the role

In the Clinical Development Department, reporting to the Senior Director Regulatory Affairs, you will be a core team member within a matrix organization.
 
You will be responsible for providing specific regulatory affairs leadership and support for a new biological product at the stage of registration in Europe and in Switzerland. You will also responsible for the maintenance of the MA (lifecycle management including variations / amendments, renewals, line extensions...). Note that these activities are managed at the global level.
 
Within the regulatory team, your main mission and responsibilities are the following:
 

Main responsibilities and key tasks

  • Participation of an EU centralized Marketing Authorisation Application (MAA) procedure and Swiss MAA under the responsibility of the Senior Director, Regulatory Affairs and in collaboration with an external partner.
  • Maintenance of the Marketing Authorisation (MA) (annual re-assessment, variations).
  • Revision of approval documents and text management (labeling management) including tracking of updates and implementation.
  • Validation of packaging artworks, labels to ensure compliance to applicable regulations.
  • Participation in the review/validation process for promotional documents and educational documents according to current internal procedures and applicable regulations.
  • Maintaining/developing knowledge of global competitive landscape, regulatory environment, and regulations.
  • Managing the regulatory Contract Research Organisations (CROs) for coordination and preparation of submissions, if applicable.
  • Collaboration with regulatory affairs representatives in the European structure (internal or external; Business unit or national entities).

Profile

Experience and Qualifications

Essential:
  • A university degree in biomedical sciences, preferably at Pharm. D or PhD level.
  • 5 years' pharma industry experience in regulatory affairs with experience in the submission and approval of EU oncology products.
  • Extensive knowledge of preparing applications and the handling of centralized procedures in the EU and application procedures in Switzerland.
  • At least 3 years of experience in Regulatory Affairs, ideally for an ‘exploitant' Company.
Desirable:
  • Strong working knowledge and understanding of biologics (mAbs) compounds is highly desired.

Technical Competencies
  • Hands-on experience in coordinating MAA submissions, and authorities' interactions through approval.
  • Experience and knowledge in the preparation of major regulatory submissions.
  • Experience in leading and providing regulatory input to cross functional project teams.
  • Knowledge of current pharmaceutical and regulatory requirements in the EU and in Switzerland.
  • Understanding of the Good Clinical Practice (GCP) regulations, ICH guidelines, Clinical Trial Regulation (CTR) and internal SOPs.
  • Sound understanding of the regulatory and quality issues related to an 'exploitant' company.

Additional Skills/ Behaviours
  • Strong ability to work independently as well as in a team matrix organization with little or no supervision, interacting with several stakeholders (internal and external) and building meaningful relationships at all levels.
  • Excellent communication skills, both verbal and written.
  • Detail oriented with accuracy, clarity and unambiguous.
  • Ability to be flexible (multi-task) and adapt to different situations quickly, and in a biotech environment
  • The applicant must be able to read, write and speak French and English (multi-lingual an advantage).
  • Problem solving capabilities - able to seek solutions and identify efficiencies.